BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEWPORT MIS CAP

    MDR report key: 3809967 · Received May 2, 2014

    Report

    Report Number
    2032593-2014-00025
    Event Type
    Injury
    Date Received
    May 2, 2014
    Report Date
    April 7, 2014
    Manufacturer
    SEASPINE, INC.
    Product Code
    NKB
    PMA / PMN Number
    K083089
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED "THE LOCKING CAP CAME LOOSE FROM THE SCREW (AFTER IT WAS IMPLANTED IN THE PATIENT) AND RESULTED IN A REVISION SURGERY. THERE WAS NO HARM DONE TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED NUMEROUS TIMES BY INTEGRA. ON (B)(6) 2014 ADDITIONAL INFORMATION WAS RECEIVED FROM THE DISTRIBUTOR. THE LOOSENING WAS DISCOVERED ON A ROUTINE XRAY. THE PRECISE DATE THAT THE LOOKING CAP LOOSENED FROM THE SCREW WAS 'UNKNOWN.' THE ROUTINE X-RAY THAT CONFIRMED THE EVENT WAS TAKEN ON (B)(6) 2014. THE SITE OF THE IMPLANT LOCATED PRIOR TO IT LOOSENING WAS THE LEFT S1. THE INITIAL SURGERY WAS A TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF). THE DATE OF THE INITIAL SURGERY WAS (B)(6) 2014. THE REMOVAL SURGERY WAS ON (B)(6) 2014. IT CONSISTED OF HARDWARE REMOVAL AND S1 SCREW REMOVAL. THERE WAS NO KNOWN RELEVANT EVENT SUCH AS A TRAUMA, FALL, ETC REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    265330 NEWPORT MIS CAP NEWPORT NKB SEASPINE, INC. M013550E

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 60MM NEWPORT CAP/ROD COMBO (60-0360)| NEWPORT DOUBLE LEAD SCREW 7.5 X 40MM (61-7540)